Celgene Corporation Stock Sinks on MS Drug Missteps

The FDA has rejected CELG's NDA

Celgene Corporation (NASDAQ:CELG) stock was down today on news of troubles with its multiple sclerosis (MS) drug.

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The problem hitting CELG stock today has to do with the company’s ozanimod MS drug. Ozanimod is a selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator that is taken orally. The drug is meant to treat patients with relapsing forms of multiple sclerosis.

According to Celgene Corporation, it has been sent a Refusal to File letter from the U.S. Food and Drug Administration (FDA). This letter rejects the New Drug Application (NDA) filed by the company for ozanimod.

The letter from the FDA states that the NDA for ozanimod doesn’t include enough information in its nonclinical and clinical pharmacology sections to warrant a complete review. Celgene Corporation says that it is seeking a Type A meeting with the FDA. It hopes to learn what extra information it can provide so that it can resubmit its NDA for the MS drug.

“We remain confident in ozanimod’s clinical profile demonstrated in the pivotal program in relapsing forms of multiple sclerosis,” Jay Backstrom, M.D., Chief Medical Officer and Head of Global Regulatory Affairs for Celgene Corporation, said in a statement. “We will work with the FDA to expeditiously address all outstanding items and bring this important medicine to patients.”

Celgene Corporation submitted its NDA for ozanimod to the FDA is December. The company was likely hoping to launch the drug in the third quarter of 2018. However, it is now up in the air as to when the drug will launch. It’s also possible that the delay will hurt the overall potential of the drug.

CELG stock was down 8% as of noon Wednesday.

As of this writing, William White did not hold a position in any of the aforementioned securities.